Functionally-closed, sterile blood processing solution system and method

ABSTRACT

Delivering a blood processing solution to blood in a blood bag includes coupling a first tube to a vented spike at one end and to a Y-shaped tube connector at a second end. An in-line microbiotic barrier filter is coupled to the first tube between its ends. A second tube is coupled to a transfer bag at one end and to the Y-shaped tube connector at its other end. A third tube is coupled to the output of the Y-shaped tube connector and sealed at its distal end. The blood bag includes a fourth tube that is sealed at a distal end. The third tube is welded to the fourth tube using a sterile tubing welder, wherein a functionally-closed, sterile flow path through which the blood processing solution can flow into the blood bag is maintained.

INTRODUCTION

The present disclosure relates to systems and processes for treatingblood that has been drawn for transfusion.

Transfusion of blood is an important aspect of treating many disordersand injuries, such as treatment of accident victims and during surgicalprocedures. According to current American Red Cross statistics, about 5million people receive blood transfusions yearly in the United Statesalone. A single accident victim can require as many as 100 pints ofblood. Thus, the collection and distribution of blood and blood productsis a vital part of the health care system. Typically, blood is obtainedfrom a donor and then processed and stored; units of stored blood orblood products are then taken from storage as needed and transfused intoa patient in need. In some cases, the blood may be an autologousdonation, where an individual donates blood in expectation of receivinghis or her own blood by transfusion during a medical procedure.

Donated blood is typically processed into components and then placed instorage until needed. Short term storage can be as long as six weeks,although blood or blood components can be frozen and stored for as longas ten years. During the processing of blood, materials may be added tothe blood to preserve the vitality of its cellular components. It isimportant that such materials be added under sterile conditions.

Such materials include those that remedy the storage lesion that canoccur in storage of blood. Unfortunately, the storage of red blood cells(RBCs) is associated altered energy production, oxygen deliverycapacity, redox status, and structural/membrane integrity. For example,the concentration of adenine triphosphate (ATP) in stored RBCs decreasesover time. Not only is ATP an energy source used by cells to catalyzenumerous enzymatic reactions, ATP also signals endothelial cells torelease nitric oxide (NO), which is a potent vasodilator. Additionally,the concentration of 2,3-diphosphoglycerate (2,3-DPG) within RBCs issignificantly reduced after 14 days of storage, and is oftenundetectable after 21 days of storage. 2,3-DPG enhances the ability ofRBCs to release oxygen by interacting with deoxygenated hemoglobin,decreasing the hemoglobin's affinity for oxygen, and thereby promotingthe release of the remaining oxygen bound to the hemoglobin. Therefore,with diminished levels of ATP and 2,3-DPG, an RBC's ability to oxygenatetissue is severely impaired.

To rejuvenate RBCs before administration into a patient, blood is oftenincubated with an RBC enhancement composition. RBC enhancementcompositions increase intracellular concentrations of 2,3-DPG and ATP,which improves the ability of RBCs to oxygenate tissues. RBC enhancementcompositions typically comprise inosine, adenine, sodium pyruvate andsodium phosphate (dibasic and monobasic). A useful RBC enhancementcomposition is Rejuvesol® Red Blood Cell Processing Solution (Rejuvesol®Solution), which has been marketed by Cytosol Laboratories Inc. (nowCitra Labs, LLC) since 1991.

Typically, such a blood rejuvenation product is added to the blood bagcontaining the RBC, by spiking the blood bag. Because spiking the bloodbag is a non-sterile process, the blood is not stored for more than 24hours after the blood bag is spiked. It is desirable to provide afunctionally-closed, sterile system and process to deliver a bloodrejuvenation product to blood (such as RBC) stored in a blood bag.

SUMMARY

In some aspects of the present disclosure a method of delivering a bloodprocessing solution (e.g., an RBC enhancement composition) to bloodpresent in a blood bag includes coupling a first end of a first tube toa vented spike and a second end of the first tube to a first input of aY-shaped tube connector. An in-line microbiotic barrier filter iscoupled to the first tube between the first and second ends of the firsttube, wherein a flow path is created from the first end to the secondend of the first tube that passes through the microbiotic barrierfilter. A first end of a second tube is coupled to a transfer bag and asecond end of the second tube is coupled to a second input of theY-shaped tube connector. A first end of a third tube is coupled to anoutput of the Y-shaped tube connector. A second end of the third tube issealed. Instructions are provided to seal a second end of a fourth tubethat is coupled at a first end to the blood bag. Instructions are alsoprovided to weld the third tube to the fourth tube using a steriletubing welder.

In other aspects of the present disclosure a system for delivering ablood processing solution to blood present in a blood bag includes afunctionally-closed, sterile Y-type tube set. The Y-type tube setincludes a vented spike that is coupled to a first end of a first tube.A Y-shaped tube connector has a first and a second input and an output,wherein a second end of the first tube is coupled to the first input ofthe Y-shaped tube connector. An in-line microbiotic barrier filter iscoupled to the first tube between the first and second ends of the firsttube, wherein a flow path is created from the first end to the secondend of the first tube that passes through the in-line microbioticbarrier filter. A transfer bag is coupled to a first end of a secondtube, wherein a second end of the second tube is coupled to the secondinput of the Y-shaped tube connector. A third tube is coupled to theoutput of the Y-shaped tube connector, wherein a second end of the thirdtube is sealed. Indicia instructs a user to weld the third tube to ablood bag tube using a sterile tubing welder, wherein afunctionally-closed, sterile flow path through which the bloodprocessing solution can flow into the blood bag is maintained.

In still further aspects of the present disclosure a method ofdelivering a blood processing solution to blood present in a blood bagincludes coupling a first end of a first tube to a vented spike and asecond end of the first tube to a first input of a Y-shaped tubeconnector. An in-line microbiotic barrier filter is coupled to the firsttube between the first and second ends of the first tube, wherein a flowpath is created from the first end to the second end of the first tubethat passes through the microbiotic barrier filter. A first end of asecond tube is coupled to a transfer bag and a second end of the secondtube is coupled to a second input of the Y-shaped tube connector. Afirst end of a third tube is coupled to an output of the Y-shaped tubeconnector. A second end of a third tube is sealed. A second end of afourth tube is sealed that is coupled at a first end to the blood bag.The third tube is welded to the fourth tube using a sterile tubingwelder, wherein a functionally-closed, sterile flow path through whichthe blood processing solution can flow into the blood bag is maintained.

In additional aspects of the present disclosure a functionally-closed,sterile Y-type tube set comprising a vented spike coupled to a first endof a first tube. A Y-shaped tube connector has a first and a secondinput and an output. A second end of the first tube is coupled to thefirst input of the Y-shaped tube connector. An in-line microbioticbarrier filter is coupled between the first and second ends of the firsttube, wherein a flow path extends from the first end to the second endof the first tube that passes through the microbiotic barrier filter. Atransfer bag is coupled to a first end of a second tube and a second endof the second tube is coupled to the second input of the Y-shaped tubeconnector. A third tube is coupled to the output of the Y-shaped tubeconnector, and a second end of the third tube is sealed.

In other aspects of the present disclosure method for delivering a bloodprocessing solution to blood present in a blood bag comprises obtaininga functionally-closed sterile Y-type tube set comprising an input tubingmember coupled to an output tubing member and providing a sterile flowpath extending from a vented spike at a distal end of the input tubingmember through an inline microbiotic filter and to a distal end of theoutput tubing member which is closed by a seal. The output tubing memberis welded to a sealed input tubing member of the blood bag using asterile tubing welder, wherein a functionally-closed, sterile flow paththrough which the blood processing solution can flow into the blood bagis maintained. The vented spike is inserted into a vial containing theblood processing solution to deliver the blood processing solutionthrough the inline microbiotic filter and into the blood in the bloodbag via the functionally-closed, sterile flow path.

Further areas of applicability will become apparent from the descriptionprovided herein. The description and specific examples in this summaryare intended for purposes of illustration only and are not intended tolimit the scope of the present disclosure.

DRAWINGS

The drawings described herein are for illustrative purposes only ofselected embodiments and not all possible implementations, and are notintended to limit the scope of the present disclosure.

FIG. 1 is a plan view including a Y-type tube set that can be used in aprocess, and as a component of, a blood processing system;

FIG. 2 is a plan view of a blood collection bag set which can be used inconjunction with the Y-type tube set of FIG. 1;

FIGS. 3A-3C are diagrammatic illustrations of sterile tube welderoperations that can be used in conjunction with the Y-type tube set ofFIG. 1;

FIG. 4 is a diagrammatic view of various functionally-closed, sterilecomponents that can be used in a process, and as components of, a bloodprocessing system; and

FIG. 5 is a perspective view of a package that can be used for theY-type tube set of FIG. 1, including indicia.

Corresponding reference numerals indicate corresponding parts throughoutthe several views of the drawings.

DETAILED DESCRIPTION

The following description of technology is merely exemplary in nature ofthe subject matter, manufacture and use of one or more inventions, andis not intended to limit the scope, application, or uses of any specificinvention claimed in this application or in such other applications asmay be filed claiming priority to this application, or patents issuingtherefrom. A non-limiting discussion of terms and phrases intended toaid understanding of the present technology is provided at the end ofthis Detailed Description.

Example embodiments will now be described more fully with reference tothe accompanying drawings. Numerous specific details are set forth inthe exemplary embodiments described herein, such as examples of specificcomponents, devices, and methods, to provide a thorough understanding ofembodiments of the present disclosure. It will be apparent to thoseskilled in the art that specific details need not be employed, thatexample embodiments may be embodied in many different forms and thatneither should be construed to limit the scope of the disclosure. Insome example embodiments, well-known processes, well-known devicestructures, and well-known technologies are not described in detail.

FIG. 1 includes an illustration of a Y-type tube set 10 that can be usedin a process, and as a component of, a blood processing system. (Theterm “blood” as used herein includes both whole blood and bloodcomponents, such as red blood cell (RBC) and plasma concentrates. Bloodprocessing tube set 10 can include a vented spike 11 with drip chamber12 coupled to the distal end of a first tube 14. Spike 11 can beinserted into a blood treatment vial or bottle 16 to complete a fluidcommunication channel between the interior of blood treatment vial 16and first tube 14.

Blood treatment vial 16 can include an RBC processing composition, whichcan increase the levels of ATP and 2,3-DPG to original levels. In someembodiments, RBC processing compositions comprise one or more of thefollowing components:

-   -   (a) about 2 to 30 g/L inosine (e.g., about 26.8 g/L inosine);    -   (b) about 5 to 15 g/L pyruvate (e.g., about 11 g/L sodium        pyruvate);    -   (c) about 0.2 to 2 g/L adenine (e.g., about 0.7 g/L adenine);        and    -   (d) about 10 to 30 g/L phosphate (e.g., a mixture of about 6.2        g/L monobasic, monohydrate; and about 14.6 g/L dibasic,        heptahydrate).        An RBC processing composition useful in the methods of this        technology has been commercialized by Citra Labs, LLC (formerly        Cytosol Laboratories), Braintree, Mass., under the mark        “Rejuvesol® Solution”.

First tube 14 can be coupled at its second end to an input of a Y-shapedconnector 18. An in-line microbiotic barrier filter 20 can be positionedin the first tube 14 flow path to filter the material flowing from thevented spike 11 through the first tube 14 to the input of Y-shapedconnector 18. One exemplary in-line microbiotic barrier filter 20 is aflat 0.2 micron filter.

A transfer bag 22 can be coupled to a first end of a second tube 24. Thesecond end of second tube 24 is coupled to the other input of Y-shapedconnector 18. Transfer bag 22 can be initially empty and used tocollect, for example, supernatant waste material. Additionally oralternatively, transfer bag 22 may initially include a processing agent,such as a wash solution.

Third tube 26 can be coupled to the output of Y-shaped connector 18 atits first end. A second end of third tube 26 is defined by a seal 28sealing the fluid channel of third tube 26. For example, seal 28 can bewelded closed using a radio frequency (RF) tube sealer (not shown).Given that no potential entry point of Y-type tube set 10 is initiallyunsealed or unprotected by a microbiotic barrier filter, this Y-typetube set 10 is functionally-closed. In other words, Y-type tube set 10provides a functionally-closed, sterile fluid pathway (via third tube26) for blood processing solution from bottle 16 to be delivered intoblood bag 32.

FIG. 2 is an illustration of blood collection bag set 30 which can be acomponent of a blood collection and processing system. Blood collectionbag set 30 can include blood bag 32 and at least one transfer bag 34.Such blood bags 32 typically include at least two integral conduits ortubes 36 and 38. One of the integral tubes 36 can initially have aneedle 40 at its distal end and is used to draw blood from a blood donorinto blood bag 32. Second integral tube or conduit 38 can initially beintegrally coupled to transfer bag 34, which can be initially empty orcan contain a processing agent.

As illustrated in FIG. 1, sometime after blood is collected into bloodbag 32, tubes 36 and 38 can be sealed. Sealing of tubes 36 and 38 can beaccomplished by welding tubes 36 and 38 closed using, for example, an RFtube sealer. Thus, the distal portion of tube 36 including needle 40that is downstream of the end created by seal 42 can be removed.Similarly, the distal portion of tube 38 including transfer bag 34 thatis downstream of the end created by seal 44 can be removed. Though notalways the case, the blood remaining in blood bag 32 at the point thetransfer bag(s) 34 are removed can be a RBC.

When it is desired to maintain the functionally-closed nature of thefluid pathway delivering blood processing solution via Y-type tube set10 into blood bag 32, third tube 26 can be coupled to tube 38 of bloodbag 32 using a sterile tubing welder 45.

Referring to FIG. 3A, such sterile tubing welders 45 can operate usingclamps 46 to position third tube 26 of Y-type tube set 10 and tube 38 ofblood bag 32 adjacent each other with the seals at opposing ends asillustrated in FIG. 3A. After clamping tubes 26 and 38 in place, a blade48 can be heated to 400 degrees and then moved upwardly tosimultaneously sever tubes 26 and 38.

Referring to FIG. 3B, clamps 46 can then translate relative to eachother to align the cut end of tubes 26 and 38 together. As illustratedin FIG. 3C, heated blade 48 can be withdrawn and the heated, cut ends oftubes 26 and 38 can be positioned against each other; thereby weldingtubes 26 and 38 together in a sterile process. Accordingly, the createdfluid pathway, including third tube 26 and tube 38 of blood bag 32 canbe joined together while maintaining the sterile, functionally-closed,state of this pathway. Notably, this can enable a blood processingsolution to be delivered from bottle 16 to blood bag 32 without spikingthe blood bag 32, for example, with a needle. An exemplary tubing welder45 that can be used is the Terumo TSCD®-II sterile tubing welder.

Because the blood processing solution can be delivered from bottle 16 toblood bag 32 via a functionally-closed, sterile fluid pathway, the bloodcan be stored for more than 24 hours after such delivery. Referring toFIG. 4, additional post-processing devices can be used to furtherprocess the blood while maintaining the blood in a functionally-closed,sterile environment.

With continuing reference to FIG. 4, the blood of blood bag 32 can beprocessed using a functionally-closed, sterile centrifuge 50. This canbe done, for example, prior to delivering the blood processing solutionto the blood bag 32 to remove components of whole blood and leave RBC inblood bag 32. One exemplary functionally-closed, sterile centrifuge 50is the COBE Spectra Apheresis System.

Similarly, the blood of blood bag 32 can be washed using afunctionally-closed, sterile cell processor 55. Such a cell processor 55can be used to remove a blood processing solution from the blood inblood bag 32, including, for example, deglycerolization. One exemplaryfunctionally-closed, sterile cell processor 55 is the Haemonetics®ACP®215 Automated Cell Processor.

Referring to FIG. 5, a package 60 for Y-type tube set 10 can compriseindicia 62. For example, indicia 62 can be printed on package 60 or apackage label. As another example, package 60 can include a printedpackage insert or pamphlet providing indicia 62. Indicia 62 can includeinstructions to seal a second end of a fourth tube 38 that is coupled ata first end to blood bag 32. Indicia 62 can also include instructions toweld third tube 26 to fourth tube 38 using a sterile tubing welder 45.Indicia 62 can further include information indicating that the blood canbe stored for use for more than 24 hours after delivering the bloodprocessing solution into the blood bag 32.

Alternatively, indicia 62 including instructions and information can beprovided separate from any package 60. For example, such instructionsand information can be provided via a website or advertising materials,including brochures and pamphlets. Such instructions and information canalso be provided indirectly. For example, package 60, advertising, or anassociated website might correlate a Y-type tube set 10 to a competitiveproduct that includes such instructions and information.

Non-Limiting Discussion of Terminology

The foregoing description of various embodiments has been provided forpurposes of illustration and description. It is not intended to beexhaustive or to limit the disclosure. Individual elements or featuresof a particular embodiment are generally not limited to that particularembodiment, but, where applicable, are interchangeable and can be usedin a selected embodiment, even if not specifically shown or described.The same may also be varied in many ways. Such variations are not to beregarded as a departure from the disclosure, and all such modificationsare intended to be included within the scope of the disclosure. Inparticular, recitation of multiple embodiments having stated features isnot intended to exclude other embodiments having additional features, orother embodiments incorporating different combinations of the statedfeatures. Specific examples are provided for illustrative purposes ofhow to make and use the compositions and methods of this technology and,unless explicitly stated otherwise, are not intended to be arepresentation that given embodiments of this technology have, or havenot, been made or tested. Equivalent changes, modifications andvariations of some embodiments, materials, compositions and methods canbe made within the scope of the present technology, with substantiallysimilar results.

The headings (such as “Introduction” and “Summary”) and sub-headingsused herein are intended only for general organization of topics withinthe present disclosure, and are not intended to limit the disclosure ofthe technology or any aspect thereof. In particular, subject matterdisclosed in the “Introduction” may include novel technology and may notconstitute a recitation of prior art. Subject matter disclosed in the“Summary” is not an exhaustive or complete disclosure of the entirescope of the technology or any embodiments thereof. Classification ordiscussion of a material within a section of this specification ashaving a particular utility is made for convenience, and no inferenceshould be drawn that the material must necessarily or solely function inaccordance with its classification herein when it is used in any givencomposition or method.

As used herein, the singular forms “a,” “an,” and “the” may be intendedto include the plural forms as well, unless the context clearlyindicates otherwise. The terms “comprises,” “comprising,” “including,”and “having,” are inclusive and therefore specify the presence of statedfeatures, integers, steps, operations, elements, and/or components, butdo not preclude the presence or addition of one or more other features,integers, steps, operations, elements, components, and/or groupsthereof. Similarly, the terms “can” and “may” and their variants areintended to be non-limiting, such that recitation that an embodiment canor may comprise certain elements or features does not exclude otherembodiments of the present technology that do not contain those elementsor features. The method steps, processes, and operations describedherein are not to be construed as necessarily requiring theirperformance in the particular order discussed or illustrated, unlessspecifically identified as an order of performance. It is also to beunderstood that additional or alternative steps may be employed.

In particular, although the open-ended term “comprising,” as a synonymof non-restrictive terms such as including, containing, or having, isused herein to describe and claim embodiments of the present technology,embodiments may alternatively be described using more limiting termssuch as “consisting of” or “consisting essentially of.” Thus, for anygiven embodiment reciting materials, components or process steps, thepresent technology also specifically includes embodiments consisting of,or consisting essentially of, such materials, components or processesexcluding additional materials, components or processes (for consistingof) and excluding additional materials, components or processesaffecting the significant properties of the embodiment (for consistingessentially of), even though such additional materials, components orprocesses are not explicitly recited in this application. For example,recitation of a composition or process reciting elements A, B and Cspecifically envisions embodiments consisting of, and consistingessentially of, A, B and C, excluding an element D that may be recitedin the art, even though element D is not explicitly described as beingexcluded herein.

When an element or layer is referred to as being “on,” “engaged to,”“connected to,” or “coupled to” another element or layer, it may bedirectly on, engaged, connected or coupled to the other element orlayer, or intervening elements or layers may be present. In contrast,when an element is referred to as being “directly on,” “directly engagedto,” “directly connected to,” or “directly coupled to” another elementor layer, there may be no intervening elements or layers present. Otherwords used to describe the relationship between elements should beinterpreted in a like fashion (e.g., “between” versus “directlybetween,” “adjacent” versus “directly adjacent,” etc.). As used herein,the term “and/or” includes any and all combinations of one or more ofthe associated listed items.

Although the terms first, second, third, etc. may be used herein todescribe various elements, components, regions, layers and/or sections,these elements, components, regions, layers and/or sections should notbe limited by these terms. These terms may be only used to distinguishone element, component, region, layer or section from another region,layer or section. Terms such as “first,” “second,” and other numericalterms when used herein do not imply a sequence or order unless clearlyindicated by the context. Thus, a first element, component, region,layer or section discussed below could be termed a second element,component, region, layer or section without departing from the teachingsof the example embodiments.

Spatially relative terms, such as “inner,” “outer,” “beneath,” “below,”“lower,” “above,” “upper,” and the like, may be used herein for ease ofdescription to describe one element or feature's relationship to anotherelement(s) or feature(s) as illustrated in the figures. Spatiallyrelative terms may be intended to encompass different orientations ofthe device in use or operation in addition to the orientation depictedin the figures. For example, if the device in the figures is turnedover, elements described as “below” or “beneath” other elements orfeatures would then be oriented “above” the other elements or features.Thus, the example term “below” can encompass both an orientation ofabove and below. The device may be otherwise oriented (rotated 90degrees or at other orientations) and the spatially relative descriptorsused herein interpreted accordingly.

What is claimed is:
 1. A method useful in delivering a blood processingsolution to blood present in a blood bag, the method comprising:coupling a first end of a first tube to a vented spike and a second endof the first tube to a first input of a Y-shaped tube connector;coupling an in-line microbiotic barrier filter between the first andsecond ends of the first tube, wherein a flow path extends from thefirst end to the second end of the first tube that passes through themicrobiotic barrier filter; coupling a first end of a second tube to atransfer bag and a second end of the second tube to a second input ofthe Y-shaped tube connector; coupling a first end of a third tube to anoutput of the Y-shaped tube connector; sealing a second end of the thirdtube; providing instructions to seal a second end of a fourth tube thatis coupled at a first end to the blood bag; and providing instructionsto weld the third tube to the fourth tube using a sterile tubing welder.2. The method of claim 1, wherein the coupling an in-line microbioticbarrier filter comprises coupling a 0.2 micron IV filter.
 3. The methodof claim 1, wherein the blood in the blood bag is a red blood cellconcentrate.
 4. The method of claim 1, further comprising inserting thevented spike into a vial containing the blood processing solution todeliver the blood processing solution to the blood in the blood bag toincrease the intracellular content of ATP and 2,3-DPG of the blood inthe blood bag.
 5. The method of claim 1, wherein the blood in the bloodbag is a red blood cell concentrate, and further comprising deliveringthe blood processing solution to the blood in the blood bag to increasethe intracellular content of ATP and 2,3-DPG of the blood in the bloodbag.
 6. The method of claim 1, further comprising providing instructionsindicating that one of a functionally-closed, sterile cell processor; afunctionally-closed, sterile centrifuge; or both; be used in processingthe blood.
 7. The method of claim 1, further comprising providinginformation indicating that the blood can be stored for use for morethan 24 hours after delivering the blood processing solution into theblood bag.
 8. A system useful in delivering a blood processing solutionto blood present in a blood bag, the system comprising: afunctionally-closed, sterile Y-type tube set comprising: a vented spikecoupled to a first end of a first tube; a Y-shaped tube connector havinga first and a second input and an output, wherein a second end of thefirst tube is coupled to the first input of the Y-shaped tube connector;an in-line microbiotic barrier filter coupled between the first andsecond ends of the first tube, wherein a flow path extends from thefirst end to the second end of the first tube that passes through themicrobiotic barrier filter; a transfer bag coupled to a first end of asecond tube, wherein a second end of the second tube is coupled to thesecond input of the Y-shaped tube connector; and a third tube coupled tothe output of the Y-shaped tube connector, wherein a second end of thethird tube is sealed; and indicia instructing a user to weld the thirdtube to a sealed blood bag tube using a sterile tubing welder andthereby maintain a functionally-closed, sterile flow path through whichthe blood processing solution can flow into the blood bag.
 9. The systemof claim 8, wherein the inline microbiotic filter is a 0.2 micron IVfilter.
 10. The system of claim 8, wherein the blood in the blood bag isa red blood cell concentrate.
 11. The system of claim 8, furthercomprising delivering the blood processing solution to the blood in theblood bag to increase the intracellular content of ATP and 2,3-DPG ofthe blood in the blood bag.
 12. The system of claim 8, wherein theY-type tube set is provided in a package comprising the indicia.
 13. Thesystem of claim 8, wherein one of a pamphlet and a package insertcomprises the indicia.
 14. The system of claim 8, wherein the indiciafurther indicates that one of a functionally-closed, sterile cellprocessor; a functionally-closed, sterile centrifuge; or both; should beused in the system.
 15. The system of claim 8, wherein the indiciafurther indicates that the blood can be stored for use for more than 24hours after delivering the blood processing solution into the blood bag.16. A method of delivering a blood processing solution to blood presentin a blood bag, the method comprising: coupling a first end of a firsttube to a vented spike and a second end of the first tube to a firstinput of a Y-shaped tube connector; coupling an in-line microbioticbarrier filter between the first and second ends of the first tube,wherein a flow path extends from the first end to the second end of thefirst tube that passes through the microbiotic barrier filter; couplinga first end of a second tube to a transfer bag and a second end of thesecond tube to a second input of the Y-shaped tube connector; coupling afirst end of a third tube to an output of the Y-shaped tube connector;sealing a second end of the third tube; sealing a second end of a fourthtube that is coupled at a first end to the blood bag; and welding thethird tube to the fourth tube using a sterile tubing welder, wherein afunctionally-closed, sterile flow path through which the bloodprocessing solution can flow into the blood bag is maintained.
 17. Themethod of claim 16, wherein the coupling an in-line microbiotic barrierfilter comprises coupling a 0.2 micron IV filter.
 18. The method ofclaim 16, wherein the blood in the blood bag is a red blood cellconcentrate.
 19. The method of claim 16, further comprising deliveringthe blood processing solution to the blood in the blood bag to increasethe intracellular content of ATP and 2,3-DPG of the blood in the bloodbag.
 20. The method of claim 16, further comprising storing the treatedblood greater than 24 hours for use thereafter.
 21. Afunctionally-closed, sterile Y-type tube set comprising: a vented spikecoupled to a first end of a first tube; a Y-shaped tube connector havinga first and a second input and an output, wherein a second end of thefirst tube is coupled to the first input of the Y-shaped tube connector;an in-line microbiotic barrier filter coupled between the first andsecond ends of the first tube, wherein a flow path extends from thefirst end to the second end of the first tube that passes through themicrobiotic barrier filter; a transfer bag coupled to a first end of asecond tube, wherein a second end of the second tube is coupled to thesecond input of the Y-shaped tube connector; and a third tube coupled tothe output of the Y-shaped tube connector, wherein a second end of thethird tube is sealed.
 22. The functionally-closed, sterile Y-type tubeset of claim 21, wherein the inline microbiotic filter is a 0.2 micronIV filter.
 23. A method for delivering a blood processing solution toblood present in a blood bag, the method comprising: obtaining afunctionally-closed sterile Y-type tube set comprising an input tubingmember coupled to an output tubing member and providing a sterile flowpath extending from a vented spike at a distal end of the input tubingmember through an inline microbiotic filter and to a distal end of theoutput tubing member which is closed by a seal; welding the outputtubing member to a sealed input tubing member of the blood bag using asterile tubing welder, wherein a functionally-closed, sterile flow paththrough which the blood processing solution can flow into the blood bagis maintained; and inserting the vented spike into a vial containing theblood processing solution to deliver the blood processing solutionthrough the inline microbiotic filter and into the blood in the bloodbag.
 24. The method of claim 23, further comprising storing the treatedblood greater than 24 hours for use thereafter.
 25. The method of claim23, wherein obtaining a functionally-closed sterile Y-type tube setcomprises obtaining the in-line microbiotic barrier filter in the formof a 0.2 micron IV filter.
 26. The method of claim 23, furthercomprising increasing the intracellular content of ATP and 2,3-DPG ofthe blood in the blood bag as a result of delivering the bloodprocessing solution to the blood in the blood bag comprises.
 27. Themethod of claim 23, further comprising increasing the intracellularcontent of ATP and 2,3-DPG of the blood in the form of a blood cellconcentrate in the blood bag as a result of delivering the bloodprocessing solution to the blood in the blood bag.
 28. The method ofclaim 23, further comprising processing the blood and blood processingsolution together using a functionally-closed, sterile cell processor.29. The method of claim 23, further comprising processing the blood andblood processing solution together using a functionally-closed, sterilecentrifuge.